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510(k) K093098

AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM by Arkray, Inc. — Product Code KQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2009
Date Received
October 1, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Urinalysis System
Device Class
Class I
Regulation Number
862.2900
Review Panel
CH
Submission Type

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  • K051432 — SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS (June 17, 2005)
  • K050790 — SPOTCHEM II LDH TEST (June 6, 2005)

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  • K121456 — AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET (February 1, 2013)
  • K102188 — CYBOW READER, MODELS 300 & 720 (August 9, 2011)
  • K101852 — CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT (March 23, 2011)
  • K091472 — URITEST 50 AND URITEST 500 URINE ANALYZER (April 27, 2010)
  • K093555 — COBAS U411 TEST SYSTEM (April 2, 2010)
  • K070929 — ACON U120 URINE ANALYZER, MODEL U111-101 (July 30, 2007)
  • K053253 — HEMOCUE ALBUMIN 201 ANALYZING SYSTEM (February 17, 2006)